Inhaled steroid as emergency treatment for patients with steroid dependency
This study aims to find out if an everyday steroid inhaler, like those used for asthma, could be used as an emergency treatment for people with adrenal insufficiency. For these patients, stress on the body can cause a life-threatening adrenal crisis because their bodies don't produce enough stress hormones. Currently, an emergency injection is needed, which can be difficult or delayed. Researchers hope an inhaler could be a quicker, easier, and less stressful way to give this life-saving medication. The study involves three small parts to see if the inhaler can deliver enough steroid to help and if patients find it a good alternative to injections.
At a glance
What is this study about?
People with a condition called adrenal insufficiency must take daily steroid medication to stay healthy. This is because their bodies don't naturally produce enough of an important stress hormone called cortisol. When healthy people get stressed, their bodies make more cortisol, but people with adrenal insufficiency can't do this. This can lead to a serious situation called an adrenal crisis, which can be life-threatening.
The usual way to treat an adrenal crisis is with an emergency injection of steroids. However, giving an injection can sometimes be tricky or delayed for various reasons. This study is exploring a new idea: what if an inhaler, similar to those used for asthma, could be used instead? We already know that steroid inhalers deliver medication through the lungs that can affect the whole body, so this might be a good alternative.
The aim of this project is to see if an inhaled steroid could be a quick and easy 'rescue' treatment to prevent or treat an adrenal crisis. If successful, it could mean that people with adrenal insufficiency could carry an inhaler for emergencies instead of an injection kit. This could reduce hospital stays, save lives, and ease the worry many patients feel about having an adrenal crisis. The study is run by Newcastle upon Tyne Hospitals NHS Foundation Trust and will take place between April 2025 and December 2027.
Key takeaways
- Aims to find an easier emergency treatment for adrenal crisis than injections.
- Investigating a common steroid inhaler as a 'rescue' option.
- Could reduce hospital stays and patient anxiety.
- Involves temporary steroid changes for some parts, with doctor supervision.
- You'll keep your usual emergency injection as a backup.
- Funded by Newcastle upon Tyne Hospitals NHS Foundation Trust.
Who may be eligible?
This study is looking for volunteers aged 18 or over. You need to have what's called 'primary adrenal insufficiency', which is often caused by Addison’s disease or by having both adrenal glands removed.
There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to get pregnant within one month. You also can't have serious lung or heart conditions, or certain mental health conditions. If you're already using a steroid inhaler or certain other medications, you might also not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have primary adrenal insufficiency (like Addison's disease)?
- Are you not currently pregnant, breastfeeding, or planning a pregnancy soon?
- Do you not have any significant lung or heart conditions?
- Are you not regularly using a steroid inhaler or certain other medications?
What does participation involve?
If you join this study, it will involve three small parts. For the first two parts (A and B), you'll need to skip your usual steroid dose the afternoon before a study visit, but only after speaking with the study doctor and if you're feeling well. If you feel unwell, the visit will be postponed. During these visits, you might feel a bit sick after a treatment called apomorphine, but this usually passes quickly (20-30 minutes). This part helps researchers understand if someone feeling unwell can still use an inhaler effectively.
In the third part (C), you'll have the option to try the inhaled steroid if you start to feel unwell or vomit. The researchers want to know if you find the inhaler preferable to an injection. You'll keep your usual emergency injection and know what to do if the inhaler doesn't work. You'll also be given a diary and contact details for the study team for advice. The total duration of your involvement will depend on which parts you participate in.
Potential risks and benefits
Locations (1)
- Royal Victoria InfirmaryApproximateNewcastle upon Tyne, United Kingdom
Common questions
What is adrenal insufficiency?
It's a condition where your body doesn't produce enough of certain hormones, particularly the 'stress hormone' cortisol.
What is an adrenal crisis?
This is a serious, life-threatening situation that can happen to people with adrenal insufficiency if their body doesn't get enough cortisol during times of stress.
What is being tested in this study?
This study is testing if a steroid inhaler, usually used for asthma, can be used as an emergency treatment for an adrenal crisis instead of an injection.
Will taking part affect my usual medical care?
You will retain your usual emergency treatments, including steroid injections. The study will provide clear guidance on when to use them.
Who is paying for this study?
The study is funded by the Newcastle upon Tyne Hospitals NHS Foundation Trust in the UK.
How to find out more
Simon Pearce
Always speak to your GP or specialist before deciding to take part in a study.
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